APPLICATION
ANDA086429
TYPE
ANDA
ORIGINAL APPROVAL
1979-04-04
LATEST ACTION
2016-01-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
METHYLPHENIDATE HYDROCHLORIDEDiscontinued
METHYLPHENIDATE HYDROCHLORIDE 5MG · TABLET · ORAL
Approval history
2016-01-21Labeling · Supplement 39AP
2016-01-21Labeling · Supplement 35AP
2016-01-21Labeling · Supplement 41AP
2016-01-21Labeling · Supplement 38AP
2016-01-21Labeling · Supplement 36AP
2016-01-21Labeling · Supplement 42 · standardAP
2016-01-21Labeling · Supplement 34AP
2011-08-31Labeling · Supplement 40AP
2005-12-28Labeling · Supplement 33AP
2004-07-19Labeling · Supplement 32AP
2002-12-09Manufacturing (CMC) · Supplement 29AP
2002-10-09Labeling · Supplement 28AP
1999-11-08Labeling · Supplement 27AP
1998-11-24Manufacturing (CMC) · Supplement 22AP
1998-11-24Manufacturing (CMC) · Supplement 23AP
1998-11-24Manufacturing (CMC) · Supplement 21AP
1998-11-24Manufacturing (CMC) · Supplement 24AP
1998-02-13Labeling · Supplement 20AP
1996-07-02Labeling · Supplement 19AP
1995-06-30Manufacturing (CMC) · Supplement 18AP
1992-01-24Bioequivalence · Supplement 17AP
1989-07-14Labeling · Supplement 15AP
1986-10-20Manufacturing (CMC) · Supplement 10AP
1984-12-10Manufacturing (CMC) · Supplement 12AP
1984-12-10Manufacturing (CMC) · Supplement 13AP
1979-04-04OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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